Evaluation of adjunctive HPV testing by Hybrid Capture II？ in women with minor cytological abnormalities for the diagnosis of CIN2/3 and cost comparison with colposcopy

The present study assesses if HRHPV testing can predict CIN2/3 in women referred for mild dyskaryosis and borderline cytological changes in an health authority with a referral policy to colposcopy after one single mild dyskaryotic Pap smear.The HPV DNA Hybrid Capture II (Digene/Abbott, Maidenhead) was evaluated on 110 consenting women with mild dyskaryosis and 23 women with persistent borderline changes, who were referred for colposcopy between May and November 2001. A cost comparison between two referral policies was performed.CIN2/3 was diagnosed histologically in 30 of 133 women (22%) with minor cytological abnormalities. As the Receiver Operator Characteristics plot suggested a cut-off of 3 pg/ml the HRHPV HCII was evaluated at 3 RLU (relative light units) and at the manufacturer's recommendation of 1 RLU. At both cut-offs sensitivity and negative predictive value were high at 97%. Specificity was low at 37% at a cut-off of 1 pg/ml and 46% at a cut-off of 3 RLU. To remain cost neutral in comparison to immediate colposcopy the costs for one HR HPV HC II must not exceed ￡34.37 per test at a cut off of 3 pg/ml.The negative likelihood ratio (NLR) was of good diagnostic value with 0.089 at 1 RLU and 0.072 at 3 RLU, which reduces the post-test probability for CIN2/3 to 2% in this population. Women with minor cytological disorders can be excluded from colposcopy on a negative HR HPV result.Specificity can be improved by restricting HR HPV testing to women with persistent borderline cytological changes or to women over 30 years.Oncogenic Human Papilloma Virus (HR HPV) genome could be found in 99.7% of 942 histologically proven cervix carcinoma [1]. HPV gene product E6 is thought to degrade the tumour suppressor protein p53 destabilizing the cell cycle, which leads to cervical cancer in susceptible individuals [2]. Cytological screening has reduced the annual incidence of cervical carcinoma from 17/100000 to 8.5/100000 in the last 20 years in the UK [3]. However up to 30